Alphanate

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Prescribing Information

For Patients

Alphanate (antihemophilic factor) (HUMAN) is a naturally occurring protein in the blood that helps blood to clot used to treat or prevent bleeding in people with hemophilia A. Common side effects include flushing of the face, nausea, vomiting, and fast heartbeat which may be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and headache may also occur.

Dosage of Alphanate is individualized, and is administered intravenously. Alphanate may interact with other drugs that affect bleeding or blood clotting. Tell your doctor all medications and supplements you use. During pregnancy, Alphanate should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Alphanate (antihemophilic factor) (HUMAN) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

SIDE EFFECTS: Flushing of the face, nausea, vomiting, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of anemia (e.g., tiredness, low energy, pale skin color, shortness of breath), new or worsening bleeding/bruising.

This medication is made from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including fever, persistent sore throat, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Occasionally, mild reactions occur following the administration of Antihemophilic
Factor (Human)13, such as allergic reactions, chills, nausea, or
stinging at the infusion site. If a reaction is experienced, and the patient
requires additional Antihemophilic Factor (Human), product from a different
lot should be administered.

Massive doses of Antihemophilic Factor (Human) have rarely resulted in acutehemolytic anemia, increased bleeding tendency or hyperfibrinogenemia.14
Alphanate (antihemophilic factor) ® contains blood group specific isoagglutinins and, when
large and/or frequent doses are required in patients of blood groups A, B, or
AB, the patient should be monitored for signs of intravascular hemolysis and
falling hematocrit. Should this condition occur, thus leading to progressive emolytic anemia, the administration of serologically compatible type O red
blood cells should be considered or the administration of Antihemophilic Factor
(Human) produced from group-specific plasma should be considered.